NCT02588963

Brief Summary

The aim of this study is to evaluate the influence of Primary and Secondary Prevention of Respiratory Infections in children up to 3 years-old attending daycare.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

October 23, 2015

Last Update Submit

March 28, 2016

Conditions

Respiratory Tract Infections

Keywords

upper respiratory tract infectionslower respiratory tract infectionshealth promotionrespiratory physiotherapyinfant

Outcome Measures

Primary Outcomes (1)

  • Health Indicators

    health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.

    1 month after intervention

Secondary Outcomes (3)

  • Severity of respiratory infection

    1 month

  • Middle Ear Condition

    1 month

  • Nasal Auscultation

    1 month

Other Outcomes (4)

  • Caregivers' Anxiety

    2 months

  • Caregivers' Knowledge about Respiratory Infections

    2 months

  • Health resources

    1 month

  • +1 more other outcomes

Study Arms (4)

Experimental Group 1

EXPERIMENTAL

Children whose caregivers were subjected to a health education session

Other: Health education session

Experimental Group 2

EXPERIMENTAL

Children who were subjected to nasal clearance protocol

Other: Nasal clearance Protocol

Experimental Group 3

EXPERIMENTAL

Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol

Other: Health education sessionOther: Nasal clearance Protocol

Control Group

PLACEBO COMPARATOR

Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session

Other: Control

Interventions

Health education sessionOTHER

It was created an education health session regarding the prevention of respiratory infections of children, according to caregivers needs. This session have a theoretical component, addressing especially modifiable risk factors of respiratory infections in children, and a practical component where caregivers can learn and practice nasal clearance techniques, demonstrated by the physiotherapist.

Experimental Group 1Experimental Group 3
Nasal clearance ProtocolOTHER

Nasal clearance protocol consists on the application of physiological serum in the nostrils of the child, followed by the stimulation of nasal inspiration in order to remove mucus from the nose and nasopharynx. The protocol is applied for 3 consecutive days, according to established criteria suggested by Postiaux.

Experimental Group 2Experimental Group 3
ControlOTHER

Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.

Control Group

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Allied Health Technologies of the Polytechnic Institute of Porto

Vila Nova de Gaia, 4400-330, Portugal

Location

Related Publications (7)

  • Ingram J, Cabral C, Hay AD, Lucas PJ, Horwood J; TARGET team. Parents' information needs, self-efficacy and influences on consulting for childhood respiratory tract infections: a qualitative study. BMC Fam Pract. 2013 Jul 28;14:106. doi: 10.1186/1471-2296-14-106.

    PMID: 23890343BACKGROUND

  • Cabral C, Horwood J, Hay AD, Lucas PJ. How communication affects prescription decisions in consultations for acute illness in children: a systematic review and meta-ethnography. BMC Fam Pract. 2014 Apr 8;15:63. doi: 10.1186/1471-2296-15-63.

    PMID: 24708839BACKGROUND

  • Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.

    PMID: 22499404BACKGROUND

  • Postiaux G, Souza Pinto V, Vieira DR, Carvalho CM. Fisioterapia respiratória pediátrica: o tratamento guiado por ausculta pulmonar. Porto Alegre: Artmed Editora; 2004.

    BACKGROUND

  • Tome D, Alexandrino AM, Santos RI, de Melo MC, Costa DA, Ferreira JP. Characterization of middle-ear condition of Oporto daycare children up-to 3 years-old: a cross sectional study. Int J Pediatr Otorhinolaryngol. 2014 Dec;78(12):2132-5. doi: 10.1016/j.ijporl.2014.09.022. Epub 2014 Sep 30.

    PMID: 25441605BACKGROUND

  • Santos R, Silva Alexandrino A, Tome D, Melo C, Mesquita Montes A, Costa D, Pinto Ferreira J. Inter- and intra-rater reliability of nasal auscultation in daycare children. Minerva Pediatr. 2018 Feb;70(1):20-26. doi: 10.23736/S0026-4946.17.04355-9. Epub 2015 Sep 11.

    PMID: 26365822BACKGROUND

  • Alexandrino AS, Santos R, Melo C, Bastos JM. Impact of caregivers' education regarding respiratory infections on the health status of day-care children: a randomized trial. Fam Pract. 2016 Oct;33(5):476-81. doi: 10.1093/fampra/cmw029. Epub 2016 Apr 30.

    PMID: 27131288DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Ana S Alexandrino, MSc

    School of Allied Health Technologies of the Polytechnic Institute of Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 28, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

PT(1)